Implementation Project (Implementation of Effective Shared Decision Making Approaches PFA)

In progress; Recruitment not applicable

Using a Decision Aid to Help Patients Make Decisions about Fibroid Treatment

Project Summary
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Project Summary

PCORI implementation projects promote the use of findings from PCORI-funded studies in real-world healthcare and other settings. These projects build toward broad use of evidence to inform healthcare decisions.

	This PCORI-funded implementation project is using shared decision making, or SDM, to help women with uterine fibroids and their doctors make decisions about treatment.
Uterine fibroids are growths in the uterus that are not cancer. They are a common health problem and can cause heavy bleeding, pain, problems with pregnancy, and preterm birth. Treatments are available for uterine fibroids; these treatments have different trade-offs.

What is the goal of this implementation project?

SDM is a process where patients and clinicians, like doctors or nurses, work together to make health decisions. Discussing the evidence for different treatments is usually part of SDM.

This project is making evidence from a PCORI-funded research study part of an SDM program. This program helps patients with fibroids and their clinicians discuss the benefits and risks of treatment options. The original research study compared three ways of treating fibroids:

Myomectomy, which is surgery to remove fibroids
Uterine artery embolization, which is a procedure to block the flow of blood to fibroids
Endometrial ablation, which is a procedure that removes a layer of the uterus lining

All three treatment options worked about the same to prevent or delay symptoms. Myomectomy and uterine artery embolization were better than endometrial ablation at helping patients avoid follow-up treatment.

What will this project do?

The project team is working with gynecology clinics in five states to make the SDM program part of regular care. First, the team is updating an existing decision aid with evidence on fibroid treatments from the study. The decision aid can be used before, during, or after clinic visits. The aid comes in multiple formats, including paper-based, picture-based, or online. It is available in English and Spanish.

Then, the project team is supporting clinics by:

Assessing how ready clinics are to support patients and doctors in making shared decisions about fibroid treatments.
Helping each clinic identify which formats they want to use and how to make the decision aid part of routine care.
Making the decision aid part of online systems that clinics use to share materials with patients.
Training and providing support in SDM for clinical teams, including doctors, nurses, and other clinic staff.

What is the expected impact of this project?

The project will demonstrate how to make the SDM program for uterine fibroids part of routine care at gynecology clinics. About 2,600 patients and 30–40 clinicians will receive the program. The project evaluation will confirm that the program is working as intended to help patients and doctors make shared decisions about treatment.

More about this implementation project:

Stakeholders Involved in This Project

Community advisory board including patients with uterine fibroids, primary care doctors, and two members from each clinic
The Fibroid Foundation
The National Uterine Fibroids Foundation
American College of Obstetricians and Gynecologists
Representatives from patient advocacy and physician specialty organizations

Implementation Strategies

Promote shared decision making.
Assess for readiness at sites.
Adapt the decision aid to include updated evidence about treatments for uterine fibroids and translate the decision aid into Spanish.
Incorporate an online, interactive version of the decision aid into sites’ electronic health record systems.
Adapt the shared decision making approach, including plans for decision aid integration, to work with sites’ existing resources and workflows.
Provide educational materials to patients as part of the decision aid.
Train clinical teams in shared decision making through in-person workshops and videoconferences.
Use a phased implementation approach, specifically a stepped wedge rollout.
Conduct site visits.
Provide technical assistance to sites, including coaching.

Evaluation Outcomes

To document implementation:

Organizational readiness
Barriers and facilitators to program implementation
Fidelity to the shared decision making process (audio-recorded visit encounters, patient survey)
Number and proportion of eligible patients who use the decision aid (EHR data and clinician log)
Number of clinicians who use the decision aids (EHR data)

To assess healthcare and health outcomes:

Patient assessment of shared decision making (CollaboRATE)
Patients’ fibroid symptoms
Patients’ health services utilization
Patients’ intended and received treatment

Journal Citations

Related Journal Citations

Project Information

Principal Investigator Principal Investigator The lead researcher and primary contact for the project. View Glossary:

Glyn Elwyn, MD, PhD, FRCGP, MSc, MB BCh

Organization Organization The institution/organization in which the project originates, or the primary institution or organization that received funding for the project. View Glossary:

Trustees of Dartmouth College

Project Budget:

$2,837,499

Project Title Project Title The original title of the project supplied by the principal investigator or project lead/team. View Glossary:

Multi-Component Implementation of Shared Decision Making for Uterine Fibroids Across Socioeconomic Strata

Key Dates

Board Approval Date Board Approval Date The date of approval to fund by the PCORI Board of Governors. The actual project start dates vary as the negotiation of project milestones must be completed before the contract can be fully executed. View Glossary:

June 2018

Project End Date Project End Date Includes the research project period and may be subject to modification to allow other research-related activities such as peer review. View Glossary:

January 2023

Year Awarded Year Awarded The year that funding for the project was approved, or the year the proposal received a notice of award. View Glossary:

2018

Study Registration Information

HSR Project Number:

HSRP20192444

Initial PCORI-Funded Research Study

This implementation project focuses on putting findings into practice from this completed PCORI-funded research study: Which Treatments for Uterine Fibroids Have the Best Results?

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Using a Decision Aid to Help Patients Make Decisions about Fibroid Treatment

Project Summary

This PCORI-funded implementation project is using shared decision making, or SDM, to help women with uterine fibroids and their doctors make decisions about treatment.